The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.

25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).

Drug: varenicline

2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).

Other Name: Chantix

Experimental: varenicline

varenicline 2mg

Drug: varenicline

2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

21 Years to 55 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

ages 21-55

ability to read and write in English

alcohol-drinking smokers

Exclusion Criteria:

any significant current medical conditions that would contraindicate smoking

current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse.

positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines

women who are pregnant or nursing

suicidal, homicidal or evidence of current severe mental illness

participants prescribed any psychotropic drug in the 30 days prior to study enrollment

blood donation within the past 6 weeks

individuals seeking treatment for smoking cessation or drinking or have attempted to quit smoking or drinking within the past 3 months